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临床试验/NCT02860442
NCT02860442已完成不适用

Early Intervention to Reduce Alcohol Misuse and Abuse in the Ohio Army National Guard

Keming Gao4 个研究点 分布在 1 个国家目标入组 850 人开始时间: 2017年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
850
试验地点
4
主要终点
Change in the Number of Drinking Days as Assessed by the Audit-C

研究概览

简要总结

The overall goal for the study is to test the efficacy of a smartphone app which includes an alcohol brief intervention (SP-BI) versus an Enhanced Usual Care (EUC) condition for National Guard members in the State of Ohio who meet criteria for at-risk drinking in the previous 4 months. The main hypothesis is that those in the SP-BI group with have reduced frequency and intensity of at-risk drinking and fewer binge drinking episodes.

详细描述

The project is a fully-powered randomized controlled trial of a smartphone app which includes an alcohol brief intervention (SP-BI) versus an Enhanced Usual Care (EUC) condition for National Guard members in the State of Ohio, who are already participating in the Ohio Army National Guard Mental Health Initiative (OHARNG-MHI) study, titled "Resilience and Risk Factors Associated with Deployment Related Posttraumatic Psychopathology", who meet criteria for at-risk drinking in the previous 4 months. After tailoring the content of the SP-BI intervention for NG soldiers, the study will prescreen ~ 8,500 individuals over the three year enrollment period to identify 850participants with at-risk drinking. TParticipants in this study will be randomized to either the SP-BI (n=375) or the EUC condition (n=375) and followed at 4, 8 and 12 months post-enrollment. Participants who are randomized to the SP-BI condition will receive an informational brochure with resources available to members of the military related to mental health and alcohol use and will download a free app on to their smartphones. The app will be developed to be used on both Android and iPhone platforms and will be used over 12 weeks to deliver the study intervention. Those assigned to the EUC condition will receive the informational brochure only.

The specific aims of the study are to compare SP-BI and EUC in: 1) Reducing the frequency and intensity of at-risk drinking at 4 -, 8- and 12-months; 2) Decreasing binge drinking at 4-, 8- and 12 months. The secondary aims are to: 1) Compare the SP-BI and EUC conditions in reducing the frequency of illicit drug use and depressive symptoms at 4-, 8- and 12-months; 2) Examine if deployment status moderates the effect of intervention assignment (SP-BI or EUC) on post-intervention drinking, depressed feelings, and other substance use.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Have a past 4-month AUDIT-C score of 5 or more for men and 4 or more for women indicating that they meet criteria for at-risk drinking, AND
  • Do not meet any of the exclusion criteria.
  • Must be a current or former member of the Ohio Army National Guard (OHARNG) or U.S. Army Reserve based in Ohio.

排除标准

  • Those who do not have access to a smart phone with either Android or iOS operating system
  • Those in active treatment for substance use disorders (i.e., report addictions treatment in past 4 months) will be excluded because the proposed SBIRT intervention is focused on early brief intervention for those with at-risk drinking and on referral to treatment for those with more serious problems

结局指标

主要结局

Change in the Number of Drinking Days as Assessed by the Audit-C

时间窗: Change over time (Baseline, 4-, 8- and 12-months post baseline)

Change in the Number of Drinks per Day as Assessed by the Audit-C

时间窗: Change over time (Baseline, 4-, 8- and 12-months post baseline)

Change in the Number of Binge Drinking Days as Assessed by the Audit-C

时间窗: Change over time (Baseline, 4-, 8- and 12-months post baseline)

次要结局

未报告次要终点

研究者

发起方
Keming Gao
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Keming Gao

Director, Mood Disorders Program

University Hospitals Cleveland Medical Center

研究点 (4)

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